Good Laboratory Practice (GLP) defines the quality standards required to ensure that your nonclinical safety studies are reliable, traceable and suitable for regulatory submission. However, GLP guidelines do not determine which studies should be performed. The appropriate study design depends on the therapeutic modality, mechanism of action, intended clinical use and regulatory requirements. 

As a specialist preclinical CRO, InnoSer supports sponsors in designing and executing GLP toxicology programmes tailored to their specific development needs. By combining expertise in exploratory pharmacology, translational models, immunotoxicology and GLP toxicology, we help you identify the most relevant test systems and endpoints to generate meaningful safety data. 

Our GLP capabilities support a wide range of therapeutic modalities, including small molecules, biologics, RNA therapeutics, cell and gene therapies. Study designs may include repeated-dose toxicity, safety pharmacology, immunotoxicity assessment, immunogenicity testing, biodistribution studies and other modality-specific non-clinical safety evaluations.